Kornimate/medical-research-clean huggingface dataset:
prospective registry to evaluate outcomes of nanobone® bone graft in acute trauma

Conditions: Fractures, Bone

Summary: this multicenter prospective patient registry was developed with the aim of documenting how orthopedic surgeons are utilizing the nanobone products in acute trauma cases along with relevant patient outcomes. these outcomes include radiographic measures such as fracture healing, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments.

this multicenter prospective patient registry was developed with the aim of documenting how orthopedic surgeons are utilizing the nanobone products in acute trauma cases along with relevant patient outcomes. these outcomes include radiographic measures such as fracture healing, instrumentation integrity, and clinical outcomes (symptom and function improvement) based on investigator and patient-based outcome assessments. the primary objective of this study is to document and analyze the use of nanobone products in acute trauma cases (as a stand-alone bone graft, or in combination with local bone only, no other bone graft substitute or biologic product used) and determine both radiographic success and clinical outcomes. all product related adverse events will be documented, tabulated, and summarized.

Eligibility criteria:
inclusion criteria: 1. subjects at least 18 years old at the time of injury 2. acute fractures, resulting from blunt or penetrating trauma * in the extremities or pelvis * requiring surgery * treated emergently, delayed or staged up to 4 weeks from the date of injury * where bone grafting is clinically indicated exclusion criteria: 1. certain fracture locations (these apply to non-unions as well) * hand - metacarpals, phalanges * forefoot - metatarsals, phalanges * skull * spine 2. fractures requiring definitive fracture stabilization beyond the initial 4 weeks from the date of injury 3. pathologic fractures secondary to malignancy 4. subjects unable to follow recommended post-operative plan and complete follow ups 5. subjects unable to complete patient reported outcome measures
real-world data in patients with breast cancer treated with abemaciclib

Conditions: Breast Cancer

Summary: the present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with abemaciclib in patients with hr-positive, her2-negative advanced breast cancer.

protocol was amended in november 2021, after the recent fda approval of abemaciclib in the adjuvant setting. on october 12, 2021, fda approved abemaciclib with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor -positive, her2-negative, node-positive, early breast cancer at high risk of recurrence and a ki-67 score ≥20%. our study will now include real-world data on efficacy and toxicity of abemaciclib in the adjuvant setting as well. 2-negative advanced breast cancer. patients who are enrolled and the patients to be enrolled will refer to a dedicated online platform (care across platform) where they can register their side-effects of cancer and the treatment received at frequent intervals. patients will be randomized in the platform in two arms with an allocation 1:1(automatically by the platform). after every report of their side-effects, patients in arm a will receive an acknowledgement and suggestion to stay in contact with their clinician. after every report of their side- effects, patients in arm b will receive an acknowledgment and suggestion to stay in contact with their clinician; additionally they will receive personalised support (as a few word text) for each side-effect reported. clinicians involved in the trial will refer patients (upon enrollment or to those already enrolled) to a dedicated online platform. patients will sign up by entering their patient id and their email address (and picking their password for security).

Eligibility criteria:
inclusion criteria: * histologically confirmed hr-positive, her2-negative breast cancer * treated at hellenic cooperative oncology group (hecog)-affiliated departments of oncology * 18 years or older * any menopausal status * treatment with abemaciclib in combination with endocrine therapy * any endocrine therapy * at least two months of treatment with abemaciclib

Keywords: abemaciclib real-world data
education program in myasthenia

Conditions: Auto-immune Myasthenia

Summary: patient therapeutic education (pte) has become "a must" in the modern management of chronic diseases. its main objective is to improve compliance with treatment and the application of preventive measures. the main goal of this study is to assess the influence of the therapeutic education program on the perception of the disease in patients with autoimmune myasthenia. secondary objectives are to assess quality of life, patient satisfaction of the pte program, the acquisition of therapeutic goals and the influence of therapeutic education on the evolution of autoimmune myasthenia study team hypothesize that therapeutic education could improve the patient's perception of myasthenia and its quality of life. by improving patient's adherence to treatments and his knowledge of the disease, it could also improve the evolution of myasthenia gravis. study team suppose that pte program can reduce the absenteeism at work, the number and duration of hospitalizations, particularly those in intensive care units.


Eligibility criteria:
inclusion criteria: * patient with generalized autoimmune myasthenia with acetylcholine receptor antibodies (achr ab) or with antibodies to the muscle-specific receptor tyrosine kinase (musk ab) * patient agreeing to participate in the therapeutic education program * signing consent * subject affiliated with a health insurance social protection regiment exclusion criteria: * patients without serological confirmation of myasthenia or pure ocular form * patient with cognitive impairment or behavioral problems that, in the investigator's opinion, will compromise their ability to comply with study procedures * refusal of the patient to participate in the study * patient who has already benefited from the therapeutic education program in myasthenia * age \< 18 y.o. * subject under safeguarding justice * subject under guardianship or under curatorship
stivarga regulatory post-marketing surveillance study in korea

Conditions: Colorectal Neoplasms

Summary: to investigate and collect post-marketing data on the safety of stivarga in real world practice in its registered indication(s) as required by health authority.


Eligibility criteria:
* inclusion criteria: * signed and dated informed consent * patients diagnosed with histologically confirmed metastatic colorectal cancer and/or metastatic or unresectable locally advanced gastrointestinal stromal tumors and/or hcc who have been previously treated with sorafenib by physician * patients who are prescribed with stivarga tablet 40mg(regorafenib) for the first time * exclusion criteria: * patients participating in an investigational program with interventions outside of routine clinical practice * all contra-indications according to the local marketing authorization have to be considered.

Keywords: stivarga / regorafenib / metastatic colorectal cancer / metastatic or unresectable locally advanced gist (gastrointestinal stromal tumors)
autologous stem cells in newborns with oxygen deprivation

Conditions: Apgar; 0-3 at 1 Minute; Metabolic Acidosis; Hypoxia, Brain; Multiple Organ Failure

Summary: the purpose of this study is to determine whether the plasticity of autologous intravenous application of cord blood stem cells would improve the clinical course of asphyxiated newborns.

when there is oxygen deprivation, more frequently in premature newborns, the brain and other organs suffer severe consequences. there is evidence that hematopoietic stem cells can help in this scenario by promoting the release of growth-enhancing factors that can help control the damage due to their "homing" capacity, which attracts them to injured sites. cord and placental blood have a high concentration of these stem cells, and because its obtention is relatively easy, it seems like a feasible treatment in perinatal hypoxia. there are current clinical trials that use cryopreserved cord blood for these patients but, to do that, the stem cells have to be frozen and then thawed to be infused, losing a considerable amount of stem cells (almost half of them). we want to evaluate the same condition but infusing non-cryopreserved autologous cord and placental blood because we believe it can be more beneficial due to the greater amount of cells infused, the avoidance of the cryoprotection agent´s toxicity and the lower costs.

Eligibility criteria:
inclusion criteria: * apgar \< 5 at 5 minutes * mixed or metabolic acidosis with a ph \<7.0 from umbilical cord blood sample * neurological manifestations compatible with hypoxic-ischemic encephalopathy * any degree of organic/systemic affectation (cardiovascular, gastrointestinal, hematologic and/or respiratory) exclusion criteria: * neurodegenerative, autoimmune or genetic disease * active infection at birth * informed consent not signed

Keywords: cd34+ perinatal hypoxia autologous hematopoietic stem cells cord and placental blood cerebral palsy
ibuprofen use on post-operative pain following cholecystectomy

Conditions: Acute Post-operative Pain

Summary: in this study, the investigators compared the effects of iv forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy. participants in group i (group ibuprofen, n=35) were administered 800 mg of iv ibuprofen; participants in group a (group acetaminophen, n=36) were administered 1000 mg of iv acetaminophen.

ibuprofen is a widely used nsaid that has antipyretic, analgesic, and anti-inflammatory effects. in this study, the investigators compared the effects of iv forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy.the participants in this study were randomized into two groups. participants in group i (group ibuprofen, n=35) were administered 800 mg of iv ibuprofen; participants in group a (group acetaminophen, n=36) were administered 1000 mg of iv acetaminophen. the investigators recorded demographic data including gender, age, asa, bmi, duration of anesthesia and surgery, ponv, los, vas scores and opioid consumption postoperatively.

Eligibility criteria:
inclusion criteria: * asa grade i-ii patients * aged 18-65 years exclusion criteria: * history of allergies or hypersensitivity to the aforementioned agents * renal, hepatic or gastrointestinal disease * significant cognitive impairment * recent use of long-term nonsteroid anti-inflammatory and opioids * oral anticoagulant use or known bleeding disorders * diabetes or any other neuropathic diseases * pregnancy or breastfeeding

Keywords: intravenous ibuprofen acetaminophen laparoscopic cholecystectomy postoperative pain control analgesia anti-inflammatory agents
acute effect of isometric exercise on blood pressure in hypertensive patients

Conditions: Arterial Hypertension

Summary: international recommendations advocate dynamic or isometric strength training as an adjunct to aerobic exercise. due to a lack of consensus, this research addresses the acute effects of isometric exercises by handgrip or lower limb isometry as a hypotensive strategy in hypertensive adults.

this study is characterized as a randomized, controlled and blinded clinical trial for the evaluators and carried out integrally in the laboratory of clinical investigation (lic) of the cardiology institute of rio grande do sul / university foundation of cardiology (icfuc). the project follows all recommendations proposed by the consort statement. the study will consist of individuals of both genders, aged between 40 and 70 years who have blood pressure above 120mmhg by 80mhg. the participants, after signing the informed consent, answered a questionnaire that will evaluate the habitual level of physical activity and will be submitted to isometric exercises of palmar grip or quadriceps muscle. pre- and post-exercise blood pressure will be monitored through the ambulatory blood pressure monitoring (abpm) method.

Eligibility criteria:
inclusion criteria: * controlled hypertensive patients (use of medication) sedentary or physically inactive exclusion criteria: * pregnant women; * unstable angina; * class ii, iii or iv heart failure; * recent cardiovascular event (last 3 months); * chronic renal insufficiency; * diabetes; * history of malignant diseases with life expectancy \<2 years; * or orthopedic limitations or any physical or mental limitation that impedes the performance of physical exercises.
comparison of new technique taping and placebo taping on patellofemoral pain syndrome: a randomised controlled study

Conditions: Patello Femoral Syndrome

Summary: we included in this study 42 individuals with patellofemoral pain syndrome. 39 of them were completed six weeks of exercise and other groups. we randomized them into three groups. one group is the star technique which is a new patellar taping technique. another group is placebo taping and the third group is only the exercise group. both groups performed exercises three times a week for six weeks. three groups were assessed with knee and hip muscles strength, shortness, performance tests, pain severity in the activity, night, rest, and knee-buckling, and kujala scale before and after 4-week exercises.

based on previous studies those participants who met the following inclusion criteria were invited to participate in the study: i) insidious onset of anterior knee pain with a duration greater than 4 weeks; ii) pain provoked by at least two of the following situations: prolonged sitting or kneeling, squatting, running, hopping or ascending or descending stairs; iii) age ranged between 18-60 years. participants were excluded in cases of the clinical history of patellofemoral dislocation or subluxation; knee osteoarthritis; injury or pain from the hip, lumbar spine, or other knee structures (meniscus, ligaments, bursa, synovial plica, infrapatellar fat); traumatic lesions of soft tissues or previous orthopedic surgery in lower limbs; having received knee injections of corticosteroids or hyaluronic acid; cognition or impaired communication; being involved in an ongoing medical-legal dispute; using canadien or walker; can not walk independently and having an allergy to taping.

Eligibility criteria:
inclusion criteria: * insidious onset of anterior knee pain with a duration greater than 4 weeks; * self-reported patellofemoral pain intensity ≥30 mm on the 100 mm visual analogue scale (vas) * pain provoked by at least two of the following situations: prolonged sitting or kneeling, squatting, running, hopping, or ascending or descending stairs; * age ranged between 18-60 years. exclusion criteria: * the clinical history of patellofemoral dislocation or subluxation; knee osteoarthritis; injury or pain from the hip, lumbar spine, or other knee structures (meniscus, ligaments, bursa, synovial plica, infrapatellar fat) -); traumatic lesions of soft tissues or previous orthopedic surgery in lower limbs; having received knee injections of corticosteroids or hyaluronic acid * cognition or impaired communication * being involved in an ongoing medical-legal dispute * using canadien or walker; can not walk independently * having an allergy to taping

Keywords: patella femoral pain syndrome exercise elastic taping pain kinesiotaping
morphological analysis and classification of posterior malleolar fractures based on ct scans

Conditions: Morphological Analysis and Classification; Posterior Malleolar Fractures; CT Scans

Summary: the study was to propose a classification system of posterior malleolar fractures by fracture lines with the use of ct scans, including 3d ct reconstruction, which can better understand morphological characteristics, analyze the mechanism and guide the surgeon to choose optimal approach and fixation.

the investigators retrospectively analyzed consecutive patients with ankle fractures from january 2013 and december 2019 . participants were included with ota/ao type 44 fractures involving posterior malleolus and ct scans. the exclusion criteria were: (1) previous ankle surgery; (2) pathological fractures; (3) previous deformity in ankle joint; (4) age ≤16 years old. finally, a total of 128 patients were included in this study. 128 consecutive participants with posterior malleolar fractures from january 2013 and december 2019. ct data were loaded into mimics software (v20.0, materialize), in which 3d ct reconstruction, morphological analysis and data measurements were made. statistical analysis was performed using the statistical packages for social sciences v23.0 (spss, chicago, il, usa). mann-whitney u test were used. p value of \< 0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * ota/ao type 44 fractures involving posterior malleolus and ct scans exclusion criteria: * previous ankle surgery * pathological fractures * previous deformity in ankle joint * age ≤16 years old

Keywords: ankle fractures posterior malleolar fractures classification mechanism
incidence of cardiovascular diseases in patients with hypopituitarims

Conditions: Cardiovascular Diseases

Summary: the aim of the present study was therefore two-fold: 1) to make a retrospective comparison of incidence of non-fatal stroke and cardiac events between a large cohort of patients with confirmed ghd on replacement therapy (including gh) and a control cohort from the general population; 2) to compare the prevalence of dm and cardioprotective medication between the cohorts at the time of questionnaire distribution with adjustment for possible confounders and effect modifiers.


Eligibility criteria:
inclusion criteria: * confirmed gh deficiency exclusion criteria: * not confirmed gh deficiency

Keywords: cardiac disease cerebrovascular disease gh deficiency diabetes mellitus hypertension gh therapy gh deficiency and hypopituitarims
cognitive training to improve work outcomes in severe mental illness

Conditions: Schizophrenia; Bipolar Disorder; Depression

Summary: this study will compare the efficacy of two types of supportive treatments for a program called individual placement and support, which helps people with severe mental illnesses find and keep jobs.

unemployment in people with severe mental illnesses (smis), such as schizophrenia, bipolar disorder, and major depressive disorder, has both economic and health-related costs. unemployed people with smis often report an improved quality of life after finding a job, through increases in self-esteem, socialization, opportunities to use skills and abilities, external structure, and income. supported employment plans, such as individualized placement and support (ips), help to place and support people with smis in jobs available in their community. however, people with smis often have difficulties keeping jobs. research suggests these difficulties are due to cognitive deficits-underlying patterns of thought. this study will test two versions of ips to see which produces the best outcomes for people with smis looking for jobs: one version will be supplemented with cognitive training (ct), which will address cognitive deficits related to work, and the other version will be supplemented with enhanced support (es), which will increase the support people with smis receive with their jobs. participation in this study will last 24 months. participants will first undergo a baseline assessment and then will be randomly assigned to receive ips with ct or ips with es. participants in both groups will complete one ips session and one support session-either ct or es-each week for 12 weeks. the ips sessions will involve working with a vocational counselor to find a job and then receiving support in training for and maintaining that job. participants receiving ct sessions will be taught strategies to improve attention, learning and memory, and problem-solving. participants receiving es will receive extra sessions of vocational support. all participants will complete assessments at six times: at study entry and after 3, 6, 12, 18, and 24 months. these assessments will include interviews about life circumstances, psychiatric symptoms, and job satisfaction. the first four assessment sessions will involve additional tests-administered with a pencil and paper or on a computer-that measure thinking, learning, memory, and problem-solving abilities.

Eligibility criteria:
inclusion criteria: * receiving psychiatric care at ucsd outpatient psychiatric services * dsm-iv diagnosis of a severe mental illness, including schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder * unemployed in the past 30 days, but stating a goal of work * fluency and literacy in english exclusion criteria: * presence of dementia * presence of mental retardation

Keywords: schizoaffective disorder major depressive disorder supported employment work rehabilitation severe mental illness cognitive training cognitive rehabilitation cognitive remediation
a study of atezolizumab in participants with programmed death - ligand 1 (pd-l1) positive locally advanced or metastatic non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab in participants with pd-l1-positive locally advanced or metastatic non-small cell lung cancer (nsclc). participants will receive atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.


Eligibility criteria:
inclusion criteria: * adult participants greater than or equal to 18 years of age * locally advanced or metastatic (stage iiib, stage iv, or recurrent) nsclc * representative formalin-fixed paraffin-embedded (ffpe) tumor specimens * pd-l1-positive tumor status as determined by an immunohistochemistry (ihc) assay based on pd-l1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory * measurable disease, as defined by recist version 1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exception are allowed: hormone-replacement therapy or oral contraceptives tyrosine-kinase inhibitors (tkis) approved for treatment of nsclc discontinued \>7 days prior to cycle 1, day 1 * central nervous system (cns) disease, including treated brain metastases * malignancies other than nsclc within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome * history of autoimmune disease * history of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening ct scan. history of radiation pneumonitis in the radiation field (fibrosis) id permitted * active hepatitis b or hepatitis c * human immunodeficiency virus (hiv) positive * prior treatment with cd137 agonists, anti-ctla4, anti-pd-1, or anti-pd-l1 therapeutic antibody or pathway-targeting agents